FDA New Drug Approval Count May Fall Back To Earth In 2016

A repeat of FDA’s record-breaking NME approval performance from recent years looks unlikely, even though the 14 novel approvals in the first half of 2016 equals the first half total for 2015, because almost one-third fewer novel candidates have user fee goals in the second half.

FDA’s Center for Drug Evaluation and Research approved 14 new molecular entities and novel therapeutic biologics in the first half of 2016 – the same number of novel approvals as in the first half of last year. But the relatively slim user fee calendar for the second half suggests that a repeat record-breaking approval count is highly unlikely.

Just over 20 novel agents are under review at FDA with action expected between July and December 2016 (see sidebar)....